26th Jan 2024
Testing is currently underway to determine the viability of the affected cryopreserved cord blood units (CBUs) by Cordlife Group Limited (Cordlife). The Ministry of Health (MOH) had previously stated on 8 December 2023 that investigations into Cordlife for the suboptimal storage temperature for cryopreserved CBUs would take six weeks or so.
2. We estimate the final results will be ready in end-March 2024, due to capacity constraints of the laboratory and the need to conduct further tests using additional samples from different parts of the tank to ensure thoroughness of the findings. Thereafter, the results will be sent to an independent expert panel for further verification. The results for each tank will be progressively finalised, with the last results estimated to be ready in end-March 2024. This process is to ensure that the outcomes of the study are conclusive and reliable, upon which clients can then make decisions.
3. As of now, cord blood samples from the remaining six affected tanks and dry shipper have been sent to a third-party laboratory to test the viability and potency of the CBUs. This covers approximately 17,300 CBUs, which belong to an estimated 17,050 clients, in the six affected tanks and an estimated 2,400 CBUs stored in the dry shipper. Dry shippers are intended for the transport of CBUs and are not for long-term storage.
4. Preliminary investigations show that two of the six affected tanks, which stored about 2,300 CBUs, were unlikely to be adversely affected by the temperature excursions. Results of the other tanks and dry shipper are not ready. MOH will await the testing results and the expert panel review to ascertain the impact of the temperature excursion on the affected tanks and dry shipper. Should the results for some of the samples be inconclusive, repeat testing and further consultation with the panel of experts will be required.
5. We understand that many parents are eager to know the outcome of the investigation and we seek their patience. The transfer of CBUs to another cord blood bank carries risks and should be an option that is considered carefully, accompanied by detailed discussions with the receiving cord blood bank. Parents are advised to wait until the completion of the testing and review of the results.
6. MOH is working closely with Cordlife to ensure that Cordlife progressively updates its clients as the analysis for the affected tanks is completed, and will guide parents on the transfer policy and processes where appropriate.
7. Separately, MOH had sent a letter to Cordlife on 22 January 2024 to rectify the full list of potential non-compliances with the Healthcare Services (General) Regulations and Healthcare Services (Cord Blood Banking Services) Regulations, by 31 May 2024. This refers to the list of potential non-compliances which were previously identified during the audits and inspections in November and December 2023.